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2 Project Planning for the CIPable Pharmaceutical
or Biopharmaceutical Facility
INTRODUCTION
Johannes R. Roebers
West Coast Engineering Biogen-idec, Inc., Oceanside, California, U.S.A.
Dale A. Seiberling
Electrol Specialties Company (ESC), South Beloit, Illinois, U.S.A.
The focus of this chapter is not to cover the vast subject of project planning, but
rather the many considerations that must be given to planning aproject that will
include clean-in-place (CIP) as the major method of cleaning the process equipment.
Successful integrating of CIP into process and facility design, and hence a“CIPable”
facility, includes far more than adding CIP skids to the equipment and installing
spray devices in process vessels. For CIP to be successful, it must be considered and
integrated into all project phases of process and facility design.
Why Do CIP?
The current production of many active pharmaceutical ingredients and most
protein-based biopharmaceutical drug products is essentially accomplished in
liquid handling processes that require the cleaning of complex and costly equipment
and interconnecting piping. The process steps involving solids or liquid/solid
separation steps also involve complex equipment, which is not easily disassembled
for manual cleaning, but susceptible, through appropriate redesign, to CIP on
production scale. Manual cleaning of equipment is also considered inefficient and
difficult to validate. In addition, regulatory agencies have increasingly scrutinized
manual, nonautomated cleaning of process equipment. Hence, the need for robust,
validated, and efficient cleaning drives the need for CIP.
If you cannot clean the process equipment and piping in arobust, validated manner,
do not even think about making apharmaceutical or biological product!
Why Focus on CIP During the Initial Part of the Life Cycle
of aFacility Project?
The process and required-process engineering is typically well defined and gets alot
of attention from the very beginning of aprocess facility project. Essential process
scale-up experiments will beplanned and executed by process development
departments. The critical process parameters from the process development work
will be incorporated in the knowledge base developed for the project process design.
Often material first produced in small-scale equipment is used in clinical trials and
therefore the process needs definition. The scale-up to the large-scale production
facility must bewell understood and should be well documented. Regulatory
agencies expect awell-documented technical transfer process asoutlined, for
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